What it is
Compounded eye drops are medications that a pharmacy prepares for an individual patient, usually after a licensed prescriber requests a custom formulation. They are made to order rather than manufactured in bulk. Compounded drops are generally not FDA-approved drugs, meaning the FDA has not reviewed that specific preparation for safety and effectiveness the way it reviews approved medications.
Autologous serum tears are one example. They are prepared by a pharmacy from the patient's own blood, and they are not an FDA-approved drug. Most amniotic-derived eye drops and serums are also not FDA-approved as drugs. Some amniotic membrane devices, such as tissue placed on the eye's surface, are regulated differently, as human tissue products, which is a separate pathway from drug approval.
These distinctions matter because the words 'regulated,' 'cleared,' 'approved,' and 'compounded' do not mean the same thing. A product being available does not mean it is FDA-approved. Asking a provider to explain exactly which category a product falls into is a reasonable and helpful step.
How it’s traditionally been approached
Traditionally, compounding has been used when a commercially available product does not fit a particular patient's needs, such as when an ingredient must be avoided or a different form is needed. Compounding pharmacies are generally overseen by state pharmacy boards, with the FDA also having a role under federal law.
Dry eye care has historically started with more familiar approaches, such as artificial tears, lifestyle and environmental adjustments, and FDA-approved prescription options, with eye doctors considering other routes depending on the individual. Some clinicians have also used compounded or biologic-based preparations for certain patients.
Amniotic membrane devices have been used in eye care settings and are handled under rules for human tissue products. Amniotic drops and serums, by contrast, are generally not FDA-approved as drugs. Different clinicians hold different views on where each option fits, and no single approach is right for everyone.
How the right eye doctor may help
A licensed eye doctor may help by examining your eyes, asking about your symptoms and history, and discussing which options, if any, could be appropriate. Only a licensed clinician can decide what is suitable after an evaluation, and nothing here promises any outcome.
A visit generally includes a conversation about what you have already tried, an exam of the eye surface, and a discussion of the pros and cons of different paths, including FDA-approved options. Bringing a list of your current drops and medications can help.
Good questions to ask: Is this product FDA-approved, or is it compounded or regulated as a tissue product? Where does it come from and how is it processed? Which pharmacy or facility prepares it? What are the risks and alternatives? What is the total cost, and is any part of it covered by insurance?
The whole-person view
Eye discomfort can affect sleep, concentration, and mood, and stress can in turn make people more aware of physical symptoms. Body, mind, and stress influence each other, so caring for the whole person can be a helpful complement to eye care from a licensed doctor.
Some people find body-based support, such as the approaches listed through Somatic Experiences, useful for managing stress. Others prefer talk therapy, such as through Therapists.plus. Neither replaces an eye evaluation, and each can be one part of a broader picture of well-being.
Keep in mind
- Compounded drops, autologous serum tears, and most amniotic drops and serums are generally not FDA-approved drugs; ask your provider about the regulatory status of any specific product.
- Only a licensed eye doctor can decide what is appropriate for you after an evaluation; this page is educational and not medical advice.
- Eye pain, sudden vision changes, or signs of infection need prompt professional attention; for emergencies call 911, and in a crisis call or text 988.
- Ask about the product's source, processing, regulatory status, and total cost before use.
Not sure where to start? Answer a few gentle questions and choose who you’d like to hear from.
Frequently asked questions
Are compounded eye drops FDA-approved?
No, compounded eye drops are generally not FDA-approved drugs. They are prepared by a pharmacy for an individual patient on a prescriber's request, so the FDA has not reviewed that specific preparation the way it reviews approved medications. Ask your eye doctor and pharmacy about the specifics.
What are the compounded eye drops FDA rules in simple terms?
In simple terms, compounded drops are made for a specific patient and are not FDA-approved, but they are still subject to pharmacy oversight and federal and state rules. The details depend on the type of pharmacy and the preparation. A licensed provider can explain how this applies to a particular product.
Are autologous serum tears FDA-approved?
No, autologous serum tears are not an FDA-approved drug. They are compounded by a pharmacy from the patient's own blood. A licensed eye doctor can explain whether they may be appropriate to consider and how they are prepared.
Are amniotic eye drops FDA-approved?
Most amniotic-derived eye drops and serums are not FDA-approved as drugs. Some amniotic membrane devices are instead regulated as human tissue products, which is a different pathway. Ask your provider which category a specific product falls into.
Are amniotic eye drops stem-cell treatments?
No, they should not be described as stem-cell treatments. Most amniotic tissue products contain no living stem cells after processing. Ask the provider how a specific product is sourced and processed.
What should I ask my eye doctor about a compounded product?
Ask about its FDA or regulatory status, its source, how it is processed, who prepares it, the risks, the alternatives, and the total cost. A licensed eye doctor can decide what is appropriate after evaluating you. Nothing is guaranteed.
Educational resource. Placenta-Derived Eye Serum shares general information and connects people with independent eye doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.